Duke experts: How to overcome challenges in vaccine distribution
Duke University experts speak about how to overcome inequities involved in manufacturing and distributing a coronavirus vaccine.
Good morning, everyone. Take Zoom just a little while to add everybody into the room. So please sit tight. We'll get started in just a few moments. Thank you. Okay. Okay. Hopefully it looks like we have everyone in the room now, so we will go ahead and get started. Thank you, everyone for joining us. I'm Gregory Philips with Duke Communications. Welcome to the latest media briefing on the Cove in 19 Pandemic. We are recording this briefing, and that recording will be available to everyone who registered with promising trials for several Coben vaccines in hand. Manufacturers and governments are gearing up to vaccinate billions of people over the next year and beyond. We have four experts with us today in vaccination, global health, law and economics to discuss the challenges and inequities involved in manufacturing and distributing and Kobe vaccine globally during an ongoing epidemic with us today is Dr Thomas Denning. He is chief operating officer of the Duke Human Vaccine Institute, a professor of medicine and an affiliate member of the Duke Global Health Institute. Good morning to you. Morning on. We have David McAdams, a professor at Duke's Fuqua School of Business who has proposed a mechanism using game theory to help ensure equitable distribution of Kobe vaccines. Good morning to you. Hello. Also with us is Arti Rai. She is a professor of the Duke Law School, where she is also faculty director of the Center for Innovation Policy. Her recent work includes a paper on the need for information sharing among vaccine manufacturers. Good morning. Good morning on. We have Dr Gavin. Jamie. Here's a professor of the practice that Duke Global Health Institute. He's also director of the Center for Policy impacting Global Health, which addresses challenges in health care, financing and delivery. And he worked with David McAdams on the game theory vaccine distribution mechanism. Good morning, Dr Jamie. Hello. Okay, Dr Denny, we'll start with you. Now that we have promising vaccine results and the expectation of an emergency youth authorization here in the US, it feels like attention is shifting to mass manufacture and distribution. Is that premature? What should we be focused on is the FDA considers the results we've had so far. Well, then there's a couple things to focus on, and obviously the first part is, you know, we need to be excited and pleased with where the science has got us in a very short period of time. If you look to previous campaigns of with other infectious diseases in terms of years to get a vaccine, so we've made a remarkable achievement. I think manufacturing scale up is a challenge when you're thinking about the number of doses that need to be produced. Whenever you do something of this size, there's there's probably gonna be some, you know, setbacks along the way. Batches that don't meet quality control and will not be able to be released. So there will be some challenges as we scale up on distribution. Yeah, there will be some challenges with distribution, but we need to look at our experiences, and we've had a lot of experience in other areas with getting distribution. And for one, if you look at the PEPFAR program for HIV, you know that's a program that has been around now about 15 years, maybe a little bit more. And we've used that program to get antiretroviral therapies throughout Resource Challenge, uh, communities. Um, it's had a good experience, I think, and scaling up it could have been faster, but it's worked s so I think we can learn. We can look toe all of our a lot of previous experiences to not necessarily reinvent the wheel. But just to learn from that and improve upon that Teoh meets the current needs, then the last thing I think that we need to be focusing on is we still need work to dio We still have work to do. We need to be thinking about the long term efficacy of these vaccines. We know that there that the data is suggesting that their their efficacy could efficacy singles from the short signals in the short term. But how does that hold up? Six months, nine months, 12 months? And is this going to be something that we're gonna have to keep doing as we go forward till we get maybe another vaccine development that gives us a longer lasting coverage? So I think we still have a lot of challenges, but I think we also it's time Thio be happy that we we are starting to see some late in this in this tunnel and hopefully some bright spots going forward into 2021. Sure, Absolutely. I think if we need anything in 2020 it is bright spots. Thank you for that. Professor Rye like to move on to you. One of the concerns that's already been aired, at least across the U. S. Eyes. This concern about pharmaceutical companies being granted exemption from liability for any injuries that might result from covert vaccine, especially as Dr Danny mentioned, we don't know what the long term effects might be. Can you explain exactly what exemption from liability means and whether it's common or particularly unusual for a vaccine? So it's not unusual for the context in which we're speaking right now, which is not the ordinary kind of preventive childhood vaccination context, although there is there is a compensation there and some relative exception reliability. But to focus on this particular exemption, this is for, um, the situation that we're dealing with now, which is seen as part of emergency preparedness generally. So there was a statute passed in 2005 called the Public Readiness and Emergency Preparedness Act. Um, known in the lingo, is for the prep act, and the reason for that was after the concerns about bioterror back around the time of September 11th. There was a lot of concern that developing emergency vaccines that at either pandemic speed or terrorist speed, um, would challenge companies because they would be concerned about liability if a vaccine had to be developed very, very quickly. As as we've seen in this case, as Dr Jenny has pointed out, it's been remarkable the speed at which things developed, and that's a wonderful. But it's also, you know, we do have to be concerned about side effects, and companies are concerned about liability. So a za consequence theme HHS Secretary has the ability under the prep back to declare an emergency. And those declarations have occurred with respect to the H one n one pandemic flu, Theo Ebola virus and the Zika virus. So this has happened before, and it's a very specific, um, set of circumstances in which the HHS secretary can declare an emergency. And he did do so on March 17th, 2020. And, um, the scope of liability protection is extremely broad. It covers, um, any vaccine, but also any antiviral drug biologic diagnostic device, as well as any device used in the administration of any such product and components. Constituent materials. One can read off the language because it goes on a great length drafted obviously very carefully by lawyers. The only exception is willful Minister misconduct. And so consequently, this is Ah, uh, something that the United States has done. I think very well now. Other countries we can talk about, but the United States has has set up a situation where I don't think there's any meaningful reason for manufacturers to be concerned about liability. Okay, got it. Thank you very much. We'll come back to that topic, but I'm glad you mentioned other countries because moving on from that. Gavin. Amy, we know that in order to successfully fight this virus or even eradicated, there has to be a global approach. You know that we have to vaccinate globally. Now, unfortunately, we know that from history. Um, we said we can't just assume that vaccination will take place on a global scale. Why is that? And what are the barriers? Well, so that's right. I mean, the first thing to say is there's a new adage in global health in public health. It's become a bit of a cliche, but it's absolutely true, which is that an outbreak anywhere can become an outbreak everywhere. So we're really not gonna bring this pandemic under control until we've controlled viral transmission everywhere. Can't just be in the rich world if we look at previous pandemics. We were already concerned based on previous pandemics, that the vaccine may not be distributed fairly globally. If we go back to 2000 and nine. Rt right mentioned h one n one during the 2000 and nine h one n one pandemic. We did develop a vaccine and rich nations entered into these deals Bilateral purchase agreements. They're called direct deals with vaccine manufacturers to buy supply of that vaccine. So the rich countries got mawr of it quicker and poorer countries were left behind. They got fewer doses slower. So we were already worried that this might happen again. And I'm very sad to say that behavior has repeated itself. Rich nations are holding the vaccine. We all know now about the Pfizer and Madonna vaccine over 80% off aled doses off. Those two vaccines have already bean purchased by rich nations, poor nations left behind. So that is an enormous concern. There is, of course, a new facility which we hope we're going to talk about today. The Kovacs facility. That is really the main game in town for trying to achieve the kind of distribution that Dr Denny talked about global distribution. It's run by the World Health Organization Gavi, the Vaccine Alliance, and Seppi in Norway, which makes the vaccines. And there is a big hope that they will be able to buy enough vaccine to distribute it to low and middle income countries. What we did and I'm gonna pass you over to David now, Professor McAdams, what we did was to say, actually, the bilateral deals that were happening right now is there a way that they could be configured? Is there a way that they could be set up? Are there certain principles that could guide those bilateral deals that could be win win globally? Could they be established in a way that benefited low and middle income countries as well? And I think I'll stop there and pass over to Professor McCanns. Sure. So, Professor McAdams, we know that Kovacs is set up is an international body, you know, that the country could buy into for distributing vaccines. So what is it that you guys have come up with that would incentivize rich countries as well as the struggling more countries. That s so we'll be into this together. How can it work? Let me just back up for a second and acknowledge that kind of this race to develop vaccines around the world has the potential to take on the flavor of what we call a zero sum game, where something we do to benefit ourselves here in United States might harm others by delaying their access to the vaccine. But it doesn't have to be that way, and that's the focus of our analysis. Is trying to find ways for win win. So the things that rich countries due to benefit themselves could actually also benefit poor parts of the world. And there's several ways that can happen. But the most important is through transferring know how in capabilities. So we've already seen this in the relationship for the Oxford Vaccine with Serum Institute in India. Okay, so that's a planned relationship. Whereas AstraZeneca has scrambling to produce doses that, as Gavin mentioned, are going by and large to the rich countries like Europe and so on there. The Serum Institute, also standing up facilities to produce a planned billion doses that will go to people in India and other lower income countries. The real question is that we're calling for more attention to in our work is what's gonna happen to the facilities currently producing vaccines that aren't yet approved that fail. Okay, we've been very lucky so far that the vaccines have been succeeding. But there are facilities all around the world that right now are churning out doses of vaccines that are not going to be distributed because they're not going to be safe or effective. What happens to those facilities? Will we be able to repurpose those to produce a successful vaccine? How quickly can we do that? Okay, so we're calling on attention to this matter, because if we can lay the groundwork for that sort of tech transfer the sort of knowledge capability transfer, weaken, stand up those other facilities faster and get more doses out into the world quicker and that will benefit of poor people everywhere. Fantastic. Thank you. And thank you to all of our Panelists for those opening questions. We've certainly got a lot to dig into here. A tous point. I'm gonna open it up to questions. Thanks to those reporters who already sent questions. I'm gonna tackle some of those in a moment. But if you have questions that you'd like to ask, you can type them into the Q and a window here on Zoom, which is in the bottom right of your zoom window. Or you can raise your hand in zoom. If you are calling him by phone, you can raise your hand by pressing star nine on. Then we can amuse you so that you can ask your question. Um, now we've got, as I said, a number of questions that are coming in advance. So I'm gonna start with those wherever I happened to direct these Panelists. If if any of you want to weigh in once somebody answer the question, then please do so, um, one of questions, Dr Danny, I'll start with you. There are a lot of questions about Children. We know that the currently vaccines that seemed to be on the cusp of approval are have all been tested on adults on the Children, very different thing. We hear lots of things about how the viruses, either as prevalent in Children or not serious, what should we expect or What is the current situation as regards vaccine trials for Children on? What would you expect to see from that over the next few months and year? The current trials have been mostly done in adults or older Children, as is best, I'm aware there are protocols being developed right now that will open very soon into the new year. A Duke will be one site where we will begin to look at clinical trials in younger Children. And this is not unusual. You most clinical trials with new you know, new products start out usually in healthy adults of different ages. And then, as as we go through that process and learned that there's they're safe, then we move into other age groups. So I think it will be key to get clinical trials performed in Children and learn that the vaccines are safe and effective. Azaz. You know, one day this may be something that is just part of, you know, well, baby immunization schedules that at a certain age, uh, you would receive this vaccine just like a group of other vaccines. But we first have to have the trials to show that it is safe for that age group? Sure, Absolutely. Thank you, Professor Roy. Question for you. Obviously, it's understandable that the companies that are involved in developing these vaccines, you know, want to be compensated for their work on, you know, they have their patterns on the vaccines that they're developing. But do you see, um, that there is a balance being struck because I'm guessing countries companies don't wish to be seen as profiteering, you know, in the midst of a pandemic, while at the same time they're obviously getting massive orders from countries for these vaccines that will allow them presumably to make a good deal of revenue from that. So do you see that? Because I know early on in the vaccine development process, there were hopes that there would be unprecedented cooperation Onda freedom of information sharing between vaccine manufacturers. Now you've written about this. So has that unfolded the way you would expect? Do you think that companies are going to take an unprecedented kind of approach to actually curing this pandemic, or is it more business as usual? So I think you those are both great questions there to slightly separate questions, and I will take each of them on a Z, you ask them. So one is the issue of price. And within that, of course, there's rich countries versus poor countries or, you know, a new infinite gradations between. So I think overall, the pricing issue is not going to be an issue, at least in the rich world. I think that in in general it appears that the rich world will be able to pay what's necessary so that individual people in the rich world don't have to pay exorbitant prices or any prices at all. Really. Perhaps, um, because this is basically what the U. S government and other rich governments have done by courting these vaccines that have just put in so many orders that there's price is that going to be an issue despite the patents and all the rest of it? Um, the the question. Now, of course, price may be an issue for the developing world or lower LME countries, and we can talk about that. That's Ah, very important issue, and, um, uh, you know whether there's going to be what's known by economists is price discrimination for those countries, or the Kovacs facility will be able to supply enough. A sufficiently low price is a very interesting question. Important question. As for the issue of knowledge sharing, well, eso Professor McAdams really And Dr Yemi really got at the heart of the question by getting Thio, you know, will we see knowledge sharing of the sort that AstraZeneca has done with the serum Institute? Um, by the Madonnas and fighters of the world, which you're using a different platform. They're using a platform called the M R on a platform, which is more tricky in some respects, all the easier in other respects. And we can talk about that if folks are interested. But, um so let's say that a facility that failed along the lines of what Professor Miss at McAdams just talking about or the vaccine that it was producing failed. Then they could be stood up to manufacturers. Marna. Would Pfizer and Madonna be willing to transfer some very sophisticated technical knowledge that's necessary to stand up that facility and move it, say, from a protein sub unit, that platform to an M R and a platform, and that would require Cem six significant technical transfer? I haven't Jaster Zeneca has been very good. I haven't seen Pfizer and modern unnecessarily stepping up. But part of the issue with all of this is also we don't know what the contracts call for in terms of repurpose ing. So the government, the U. S. Government has said that it's willing to repurpose facilities and so forth and so on. But whether these contracts say that that the companies in question have to transfer the technical knowledge, at least I'm not aware of sufficient transparency. To know on transparency with respective contracts is huge issue as well. Sure, Absolutely. Thank you. Um, Dr Jamie, I'd like toe move onto you, Bond touch on one of the elements of this knowledge transfer. This important, one of things we know is that in the US and in other countries, they were gonna be these challenges logistical challenges of getting vaccines, especially the fires of vaccine that has to be kept so cold into rural and remote areas. If we're going to achieve this kind of global vaccination that we need, can you talk a little bit about some of those challenges of reaching the most remote communities in the U. S. And abroad on dwhite kind of understanding that you have right now is the approach. Is that gonna be taken toe? Do that when it's so impractical. Sure. So a couple of things. Firstly, Gary, the Vaccine Alliance has bean supporting low and middle income countries for over a decade. Now in In distributing vaccines, Gabby sits in Geneva. It doesn't have country officers. It funds countries to deliver vaccines themselves. So these air national programs and Gabby has being helping toe overcome bottle next for many years now on to set up supply chains. Of course, the second thing to say is depending upon the vaccine, there are going to be so called cold chain challenges. You know, one of the vaccines, as you know, has to be kept as cold as the South Pole, the fires of vaccine, and that presents challenges. The third thing I would say is that there have bean successful vaccines distributed in pandemics in low income settings, Ebola in the DRC, for example showing that it can be done One of the biggest challenges I think. And we haven't really talked much about it yet for this pandemic is that the people who are going to be vaccinated first presumably are going to be older people, older people, particularly with medical conditions who are medically vulnerable and health workers on the programs that I just mentioned that Gabby has bean funding year on year. Those have mostly bean childhood vaccinations, Um, so that presents somewhat of a challenge. We don't have a huge amount of global experience in low and middle income countries reaching adults with vaccines to some extent with pregnant women, yes, but less so with older adults, perhaps with the exception of flu vaccine campaigns in some countries. So I do think that is going to be a challenge. And then just the last point I would make back to Dr Denny's discussion about the child safety of the vaccine in Children. My pediatrician colleagues have tried to convince me, and I think I am convinced now that we are going to be asleep at the wheel on this issue. If we don't think about Children, we have excellent vaccination programs and delivery channels for reaching Children ready to go now. And actually, one way to reach herd immunity more quickly would be to vaccinate Children because it could take a long time to set up these You know delivery channels for older people. They don't really exist right now, and I haven't really got my head around that. So I think there is some urgency about knowing the safety and efficacy and Children, for that reason. Gotcha. Thank you. And I think we'll certainly come back to this thing, this issue of Children. For right now we have a raised hand as well as some questions of the Q and A that I'll get to in a moment. But if we could go ahead and I'm you, Emily, I think you are muted, so you can go ahead and ask a question. Hey, this is Emily Cop with CQ roll call. Um, I wanted to ask. There was ah prediction. Yesterday, an expert said that he thinks that we can vaccinate the global population in two years because these memoranda vaccines, they're so easy to scale up. And I'm wondering if you could weigh in on whether you think that's a reasonable expectation on. I'm also wondering if you think the change of administration will affect the U. S. Is approached Thio participating in, um you know, global technology sharing. Andi will change the U. S s approach Thio transparency regard with regards to the sea, you know, contracts with pharmaceutical companies. Thanks. Who wants to take that one? I was just about to say the same thing. E. I'll kind of comment on the manufacturing of the Arnas. You know that isn't it z the easier platform for scaling up? You know, it does provide some challenges for distribution and the cold chain, as we've talked about, but it's certainly easier to get large batch numbers of vaccine via the RN, a method than some of the traditional ways we have. You know, a flu vaccine, for example, each year what we call protein based vaccines or other types of vaccines. The manufacturing process there is a bit more challenging when you need large doses. So eso the RNA platform does give us hope that we can make the quantities that we need more, uh, that we need for the distribution. And I guess I'll turf Thio Gavin or others on the the political aspects of going forward and how we play in the world. Thanks eso a couple of things on the global side. First of all, if all goes according to plan, you know if everything lines up perfectly, Kovacs hopes to have enough doses toe vaccinate a billion people by the end of next year. So that Z gonna require probably a two dose regimen. So that's two billion doses by the end of the next year that would vaccinate only 20% of the population in each low income and lower middle income countries. Those are the two income groups that Kovacs will be supplying vaccine to funded by donors. So that's only 20% off the of the population. I'm looking today at the latest numbers just so I don't, you know, mess it up. Right now, Kovacs has only secured 0.7 billion doses, so it's nowhere near what they're hoping for, compared to 3.8 billion by high income countries. So I do think there are going t be some equity challenges on the successful failure of global heard vaccine herd. Immunity is going to require Kovacs you know, Thio be able to procure more doses than at the current rate off procurement. Then on the change of administration yesterday, I'm sorry to plug myself here, but I'm a columnist for Time magazine on now he Bedelia Boston University who directs the Special Pathogens unit. We have a piece out that is aimed at the Biden transition team. We sent it to the team that it sort of lays out some of the things that we think the transition team could be doing now, Um, during the lame duck period. Andi, I do think partisan politics aside, I do think we're going to see a sea change, not just in terms of the competence. We've had the most incompetent federal response, probably of any income country that I can think off. We obviously have, you know, 1/5 or so of the world's deaths and cases. We haven't had a Nev Idan based science science based response. It's really bean distressing. I do think you're going to see a sea change in basic competence, but also I do think we will be returning to the international global health system. We will we will return to the World Health Organization. My prediction is that the USA will join Kovacs. It has not to date. They have sat it out on. I suspect they will. So I do think that the US will be returning to the international system in that way. Okay, Thank you very much, Emily. I hope that that answers your question. So can I just jump in on the transparency piece of the question, which I think, if you don't mind, um so the transparency piece of the question. I agree with everything Dr. Yemi has said regarding the change in administration yielding a sea change in many aspects, whether it will really just see change and transparency. I'm not as sure the intellectual property questions tend to be a little less, um, divided along partisan lines. And, um, it is the case that the intellectual property issues are often as much Democratic issues is they are Republican issues. So that will be an interesting set of questions because there's a little bit of, ah, double intellectual property question because it's the intellectual property that is discussed in the contracts itself. And then there's the secrecy around the contracts because the contracts themselves or sometimes considered or often considered to have trade secret aspects and that is ah less by part of less partisan issue than I'm here. I'm really my partisan prayers. Then some of the basic faith and science stuff that I think one party is probably more, um, on the side of science than the other right now. Sure. Thank you. All of you for those answers. We've got some questions here in the Q and A We could go on and tackle. Uh, Doctor Daniel, if you wanna tackle this one, do we know if any of the vaccine candidates actually prevent infection? And if not, could vaccinated individuals also potentially transmit the virus? Really? Eso. I think we'll learn more of this when we see the data that's presented at the FDA in another week or so. So what? What I think we do know is that 90 each of the vaccine suffice er in Madonna have shown to have 95% efficacy in what I have read is preventing infection or reducing severe disease. So, you know, it's not uncommon that that a vaccine does not totally prevent from being infected. But if you do get infected, the vaccine immunity that's been generated kicks in on overdrive at that point and helps to contain and minimize the consequences of the infection. So I think we'll learn more of that. Aziz. We see data come out in the FDA review gotcha. Thank you. Another question in the Q and A, which may be yourself or our Dr Yomi could tackles. It says that given the racial income disparities we've seen in terms of co vid risk and deaths here in the U. S. Is there concern that we'll see the same kind of unequal access to in low income communities? Azi regards the vaccines on what steps, if any, could the federal government take to ensure equitable distribution? At least here in the US I'm happy. Thio. Go ahead. I'll defer to you, Gavin. I'll defer to you. Look absolute. The same inequities that we've been talking about globally that could happen could happen here, you know, on these shores, if we're not careful, the data are very clear right now that black Americans, Latin X Americans, Native Americans, the death rate from covered 19 is higher than in the general population. Um, that is related to deep seated structural racism, the legacy of slavery of Jim Crow, of red lining that is related to who has who is taking jobs that put them at higher risk, you know, from care homes to meat packing warehouses. You know, these are the this is deep seated. These inequities were present before covered 19. They've b'more starkly exposed, so I think that every panel that has looked at how vaccine should be prioritized. It was very, very impressed, for example, by the Institute of Medicine. It's not called that anymore. They changed their name years ago. I just can't get it out of my the National Academy of Medicine. That panel recommended the people of color should be early in the prioritization. I was also incredibly happy to see that they also recommended people who are in jails, prisons, ice detention centers, juvenile detention centers, those who are homeless. You know people who are at higher risk should be vaccinated early. Um, so there's a lot of thinking now a lot of scholarship, particularly among scholars, off color themselves in how we might do that. We have to, of course, also recognize at the same time that there are communities that may be suspicious off the notion off early vaccination again because of the legacy off medical experimentation. Perhaps most famously, the Tuskegee experiment where black Americans were left with syphilis without treatment to watch what would happen that went from 1932 to 1972. That is recent. This remaining suspicion absolutely warranted. I think we need to tease out when people talk about vaccine hesitancy. I think we have to figure out what's going on. Is it? You know, in some communities that suspicion is completely understandable. So I think working with communities is key. This afternoon, Lavagna of a pseudo van from Duke Global Health Institute and I will be on a panel at the Triangle Global Health Consortium. She is an expert on vaccine hesitancy in a non teasing out, you know, what does it really mean and how you overcome it? Working with communities is absolutely key. Andi, I think what? Some of her research on I'll stop here on this one, in which I find really interesting is that one of the most powerful predictors of whether a community will take up a vaccine is whether the health providers in that community take it themselves on. Go out there and say, Here, look, watch. It's going in my arm today. I believe in it trust, you know. Look, look. This is this is how I much I believe in it. And I think that since this process. You know where there was concern that the emergencies authorization would happen very quickly before the election, For electoral reasons. That's off the table now. I think that medical community is breathing a sigh of relief that we can, I think. Now go out and say this. You know, we believe actually, on this nothing was rushed here, but electoral reasons we believe in it. We trust it. So I think that is going to be an important step going forward. Yeah, I would build on what Gavin said. I absolutely agree. And I I take it a step for I believe we need what I'm calling vaccine ambassadors for the every community, uh, setting. And I was pleased to read this morning in the paper. Where are, you know, President? Former Presidents Bush, Obama and Clinton have agreed to be filmed taking the vaccine early on, but I think that's a wonderful start, but it has to go down toe every level into local communities where community leaders, church leaders, other other people that have status within a community say this is safe. This is good. We must do it and participate. I think if you see that, then you will start to see people being more willing. Thio, take the vaccine early on. One last thing. Horrified to see the notion that prison guards might get it. But not people in jail themselves. Incarcerated people. That is horrific. Absolutely. Thank you both for that. And thank you. Gathered for highlighting the work of Lavagna pursued a van we've had on the previous briefing, hoping to have her back later this month or next month on this vaccine. Hesitancy Question. Professor McAdams, I'd like to come back to you. The mechanism that you guys proposed for international, um, equitable distribution. The vaccine is based in game theory, which is your area of expertise. You've applied that toe countless real world situations from, you know, sharing water resources in the Midwest to saving the white Rhino. I'm curious to put you on the spot here because we have this vaccine hesitancy issue. And as Dr Jamie pointed out, it's so multi layered. But we need thio incentivize people. We need to encourage people convinced them that the vaccine is safe and get them to take it. Do you see any way that the game theory could be applied in that situation as a way of either helping understand the vaccine is safe or emphasizing how important it is to protect themselves and their communities. I thought about this, so I don't think there's a magic bullet sort of game theory solution to pull out of bag. Um, I think the perspective that Dr Denny and the others were mentioning is right is that this is a relationship issue. So a lot of people just aren't cable, aren't equipped to judge for themselves the safety of the vaccine, so they look to social cues. And unfortunately, a lot of the discussion we've been having around vaccines has been politicized. And so this this puts us in the hole and Thio dig out of it. I think a good approach is to a doctor, Denny said, to approach people that others trust and start spreading awareness and comfort that way. So, no, Unfortunately, I don't think there's a magic bullet here. Um, but just a lot of work at the community and personal level It absolutely, thank you very much. We've got more questions that you and I are gonna get through as many of them as we can We also have a raised hand, eh? So we could go ahead and you a lot of golden. And please go ahead and ask your question. OK? Not hearing anything there, but I see that same question has been posed in what's posted the Q and A that seems to disappear on dinner. If you're not there, we're gonna I'm gonna move on and maybe come back to you. If you are still there, I would like to ask you questions. So we have another here, which I think Dr Denny might be good for you to tackle. Um, if approximately 50% of the U. S. Was vaccinated by the end of next year, do we have any sense of what that would do for infection rates? Would we expect them to have fallen proportional to the amount of people who have gotten the vaccine? Um, and I guess, at what level of inoculation could we reach a point where mask and social distancing would no longer be required? I realized this is a crystal ball type question, but anything that any of you can contribute, we'd love to hear. So both the Pfizer and Madonna vaccine if it holds up. We're what we're hearing. Is there a 95% effect of a T least in the short term? Um, that is on a new equivalence of what a lot of us referred to as a gold standard vaccine is measles. Measles protection from measles vaccine is incredibly well, so So that's great promise there, I think. And what the what? The numbers we're looking at a zai recall some modeling, and maybe maybe Gavin is up on this more. But I recall some modeling earlier in the year that said that if we had a vaccine that was least 70% effective, and we vaccinated three quarters of the population that that would be enough to eradicate the disease. So if you extract relate that to what? The question is here, Uh, we have a 90. We have two vaccines with 95% efficacy. If we get 50% of the population, uh, covered, I I think that puts us on a great trajectory of starting to eliminate this I I see 2021 is a transition year that we as we begin to get more people vaccinated. Andi, I think it'll take us a least into the second quarter or in the second quarter to start seeing large numbers there. That's slowly we begin to come out of the social distancing, Um, you know, public health behavior of maybe less masking or or less social distance. But I do see that the majority of 21 I think we're still behaving like we're behaving right now. So we make sure we get people vaccinated and then truly start to understand the long term efficacy. What we have to remember is that the vaccines right now that are being considered for EU approval are are being approved based on clinical endpoints, that is, who got infected or who did not get into the comparing the placebo in the treatment group. There is a massive amount of work right now underway in in the operation warp speed labs that are beginning to test the samples from these individuals to see what type of antibody levels they have. And specifically, what type of what we call neutralizing antibody is present and that that will help toe give us a better understanding of how robust of a response is generated from these vaccines and for long term Gotcha. Thank you very much, Dr Jamie. Let's move on for you. We have another question. Um says there are more vaccines beyond just the Oxford adviser. Madonna vaccines. But how does approval work in other countries? Onda. How does that work with Kovacs as regards? Like do countries rely on Kovacs for approval? Or is that purely, you know, for a distribution mechanism? No. So there's a great question. It's actually very simple. One toe answer. The only vaccines that will be distributed through Kovacs, similar to the only vaccines that are ever distributed by Gabby. The vaccine lives. They have to go through what's called pre qualification at the World Health Organization, so they need to be W h o pre qualified for Kovacs to include them on dso some of the vaccine that you may hear that you may already have heard about. We're not really sure what's going on with the Sputnik vaccine there, maybe vaccines in China that if those don't get w h o prequalification, they will not be included in the Kovacs distribution. Gotcha. Okay, I wanted to just if you don't mind, just go back to Tom Tom Denny's brilliant point about the I think it's a year. I think he's right. I think it's a year off us masks and distancing. Probably. I do just want to point out that there are many countries in the world right now that have essentially ended community transmission on. We shouldn't lose sight of the fact. Obviously, I'm is thrilled. I will go to my grave believing I'm a passionate believer in science and technology, and science is our way out of this. But I would have loved to have be starting at a point where Taiwan is, or New Zealand or Australia or Vietnam or Mongolia or South Korea or China with almost no cases. You're gonna we're gonna We may have 400 deaths by the end of January. You know, we're sort of hovering at 200,000 new cases a day. Yesterday we had the largest number of deaths in a day in the whole of the pandemic. That is not a good place to be starting a vaccine campaign. So we shouldn't forget. I wish I was those countries that end of transmission without a vaccine. What a wonderful place they are in Andi. I'm not super optimistic that the current government has got its act together on distribution. They really bungled way. We went beyond fumbling the ball on testing, on tracing, on protecting health workers from PP, so I don't have a huge amount of confidence in distribution currently. So I do think we've got a T least a year ahead off these so called non pharmaceutical interventions not distancing, masking, avoiding crowds and so on. Gotcha. Thank you. And, doctor, um, I'll stay with you for another question we have in the Q and I, you know, we've talked about the inequities of the difficulties involved in, um getting vaccines to remote places. Given that we know with the ongoing pre existent, um, structural issues there are in low income communities receiving a vaccine, would you expect that there will be a delay there in this real world that we're in and knowing that these inequities exist? Are those likely even though we have levels of priority, you would expect first responders and frontline workers and and the elderly to re be receiving vaccines should we expect in rural areas, even those, um, most at risk are gonna be way delayed in getting their vaccines? I mean, Dr Denny probably knows more about this than I do. Certainly the has been reporting on the the lack of these super refrigerators in rural areas with the one vaccine that needs super refrigeration, that could be a delay. One thing that I would say is that I'm sorry. I am standing very partisan here. But if you do look at the transition team, the covert 19 folks on that team, several of them have spent their life studying in equities on I think, Get that. This is really this question of off distribution of the vaccine is intimately tied up with health inequities on racial injustice. And so I am hopeful that there will be there will be awareness in the incoming administration of the need toe, you know, go the final mile, reach those who have not. Traditionally, Bean reached before eso. I'm cautiously optimistic on that front. But yes, there will be greater challenges in rural district's Dr Denny. Anything to add on that? Sorry, I was muted. I agree with Gavin. We've learned from the HIV pandemic that you know, resource challenge areas have difficulties with refrigeration and storing of samples or running laboratories and where refrigeration and electrical, you know, consistent electricity, eyes important. And this is just gonna parallel that same, that same experience. So we're gonna have to be prepared to supplement those areas, provide portable types of cooling devices to get vaccines distributed. If all the vaccines were gonna be dependent on the cold chain, ideally, we'd love to have a vaccine. It was developed that did not have cold chain issues. But I think we have to work with what we have and begin to plan. Thio have distribution that includes adequate cold chain provision. Okay. Thank you. Both doctors, any? We've had a version of this question come in a few times and you tackled it somewhat in your opening comments, but likely to expand on if you can. You talk about efficacy. We've got a lot of questions about how long the vaccine will last or how long the protection from the vaccine will last. Obviously, I guess the only thing that will tell us that definitively is time, but what do we know at this point about the however long lasting the protection could be from any of these promising vaccine candidates. Well, I think we know what we know from the data that we're hearing and that is that short term eyes partner, part of the clinical trials process. We know that the groups that receive the vaccine had a you know, there was a 95% efficacy and either reducing, uh, severity, disease or in in individuals becoming infected. Unfortunately, that's that short term that you're talking about three months there, four months of study. There will be studies that will continue. That will be what we call the long haulers type of approach where you will continue to follow up people and and look for, uh, long term protection. But until we actually get more, uh, markers, what we call of protection antibody levels and functional antibody levels and understand that we're not going to know if you're going to need to take this, be boosted once a year or be boosted, you know, every five years I mean, this could be something. In the end, it ends up being a a cocktail or piggyback with annual flu vaccine. Um, or way could have you know, future developments with vaccines that end up being better than what we're having right now. Form or adorable or robust immunity over time. So I would just say this is all a work in progress. And And we need to stay with this yet, uh, to get more data so truly understand, Uh, you know how good these vaccines they're gonna be for long term? Sure. Thank you, Professor. I'd like to come back to you. You know, we know that we will need billions of doses of vaccine to approach covering the globe. But the manufacturing process, obviously the intellectual property the companies have is it is a huge part of that. So how does the intellectual property over manufacturing processes fit into the process here in terms of the massive scale a vaccine manufacturing that needs to take place? So this goes to a larger question of developing capacity in low and middle income countries were generally for large molecule, um, situation. So it's so vaccines and in so called biologics are large molecules that air generally harder two manufacturer notwithstanding issues about mRNA, which we can get into. I think there's some dispute about whether and Martin is quite Aziz ia's, as some people have made it out to be all that I'm not a scientist. So I will defer to those who say that the scientists who say that the lipid formulation issue is not going to be a big issue, for example so But the bigger the the overall question is, you know, especially for future pandemics and also for this pandemic, perhaps depending upon how much indigenous manufacturing capacity is needed in low and middle income countries, we really do have to think, um, about how to develop that capacity. And that has been a an issue for of for global health analysts for a very long time. And I think it's even more important now that we're seeing some evidence of so called vaccine nationalism, and I think that that is a real concern. I mean, Kovacs is great, but I think as a Z, Dr Yemi has pointed out, it's not gotten the number of doses it needs, and there is a fair amount of vaccine nationalism. So I think it would be prudent on the part of the global health community to think very carefully about how toe develop more indigenous innovation capacity, and that might require, um, I mean, I suspect in some cases it will require developing it from the ground up and not even waiting for a tech transfer from companies that are very very, um, shall we say, um, cautious about letting go of any of their intellectual property? Okay. Thank you. Thank you very much for that. And somewhat related to that doctor. Any doctor? Jamie, if you could speak to this, we at the moment. Obviously, we have three particularly promising vaccine candidates, and it looks like, you know, the doses are being sold in advance, and so they're gonna be spread across the world. Is there a chance that despite the promising results, we could find that one or more of the vaccines is a lot more effective than one of the others? And so countries that have opted for one particular vaccine may find that they end up having less protection thin. Another country that went for a different candidate? Or is it the case that based on the promising results there, all they all appear to be so effective that it wouldn't make a significant difference? Can we Can we, uh, estimate how that might unfold? Hey, E in area A, um, I'm not sure if your response was garbled for everybody else. I had a bit of trouble hearing you. I think there might be a problem with your audio. Yeah. No, it's still coming. It's still coming across really, really garbled. So I'm not sure exactly what happened there, but what? We're trying to figure that out. Dr. Denny, do you have any perspective on how the the difference between vaccines could play out across countries? I think short term, they're gonna be equivalent. I think what we know is they're both 95%. Um, uh, you know, efficacy starting out. I think what we'll drive this is when we get into this six months, nine months a year out. If we start to learn that, you know, if for some reason a number of vaccine ease in one particular product, get infected and have more serious, um, you know, courses, other disease than that may start to switch or, you know, make make a trend a little bit differently. But I think in the beginning, there both starting out about equivalency is what? What? I would, um, frame it on. I'm not sure if Gavin is agreeing with me or disagreeing with me, but maybe you could be a Maybe you could be had thumbs up. Okay, so they're Ugo. You're my friend. You're in a submarine. Yeah, Z now, now, without it echo. So I'm not sure exactly what's happened. I'm using myself. Okay, We're gonna We're gonna move on briefly here. And this would be a question for Gavin if it can work. But if not maybe, Doctor, you could tackle this one. Um, somebody has asked about the UK giving the green light to the fires of vaccine faster than the U. S. Obviously, every country has their own kind of regulatory approach. But is, uh, this particular questions asking why that waas is it simply a matter that they moved more quickly or are there other factors there? Yeah, uh, still have the same issue. You may wanna log out and come back in again. Maybe that's I hate to say that to you, but, um, so I can jump in just for a minute on the doctor. Denny, you want to do, um, the only part I would say I e think you probably is that it's my understanding and the process that FDA digs a lot deeper in looking at all the records that air coming in, uh, to say, look at source documentation where the UK system is a bit more, uh, they take what is given to them and don't necessarily go back to a lot of source documents, uh, in in in the laboratories or part of the clinical trial books. That's that's my understanding. That is one of the if you will say the bureaucratic parts of it. But I'll defer to Governor. Are you in more detail? Can you hear me now? Uh, Professor, Professor, right. What was the point? You were about things is just a point related to the way that this all worked out. Recall that when it was politicized prior to the election, the FDA took a bold step and put out guidance regarding how it would implement you A and that guidance. In addition to the fact it's generally a little bit, I think, more cautious than than, um, the U. K. That guidance specifically said that it would require clear and compelling evidence of safety and efficacy. And so it was Ah, clear response, I think, to the politicization. And that may have some consequences downstream. I don't think it will have much I think will be soon. Be ready to approve under EU a. But it was, ah, bold and I think very necessary move on the part of the FDA to push back against the White House before Gavin jumps in, just in case anybody missed the context. The EU is the emergency youth. Also, youth use authorization that the government is expected to grant to the vaccines to get them into manufacturing more quickly. A doctor. Jamie, please go ahead. If you can hear me, yep, they just very quickly. I mean, not much tried to that. Just that Dr Denny is right. I would say the U. K regulators might are excellent. I trust them. My family. You know, I have a physical therapist sister who works on the covert war that the main London's main coronavirus unit. She'll be getting it soon. Perhaps a surly is next week. So you know, I don't think they cut corners, but their process is different. They used They've used rolling data all the way through the year. That's the difference on day arm. Or I would say they work more with company data and don't do the kinds of absolutely unbelievable checks and balances the FDA do, which is really the gold standard for the world. Re analyzing data, um, is really astonishing, so I think that's part of it as well. There was some mumbo jumbo total nonsense about how Brexit allowed Britain to move faster. That's rubbish. That's just a lie. They had the authority to move this quickly under you rule. So Brexit was nothing to do with it all. Eso that's the story. Okay, excellent. Well, thank you. And we've just about reached time here and we seem to have gone through a with questions at the Q and A. So I think we will call it there. Thank you, everyone for joining us and for rolling with the punches. Dr Jamie Well done for figuring out your Darth Vader voice issue, thanks to our Panelists RT riot, Thomas Denny, David McAdams and Gavin Amy for sharing your perspectives. If you'd like to be notified of upcoming briefings, please email Duke news at duke dot e d u. We will be back next Thursday, the 10th at 11 a.m. When we'll be talking about public health messaging and vaccine resistance and how to break through that particular noise. So please join us for that. In the meantime, please stay well. Stay home and wear a mask. Thank you. And have a great day.